Second Meal Effects of a Wholegrain Cereal Product on Blood Glucose Response
29. juni 2022 oppdatert av: Aventure AB
The aim of this study is to investigate second meal effects of a wholegrain cereal product on blood glucose response.
The wholegrain cereal product will be consumed in the evening and blood glucose analyzed after a standardized breakfast meal the following morning.
Studieoversikt
Status
Fullført
Forhold
Studietype
Intervensjonell
Registrering (Faktiske)
17
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Lund, Sverige
- Aventure AB
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
35 år til 65 år (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
- Male or Female, 35 to 65 years of age
- BMI 18.5-29.9 kg/m2
- Agree to maintain consistent dietary habits and physical activity levels for the duration of the study.
- Healthy as determined by medical history and information provided by the volunteer.
- Willingness to complete questionnaires and follow instructions associated with the study and to complete all visits.
- Has given voluntary, written, informed consent to participate in the study.
Exclusion Criteria:
- Elevated fasting blood glucose (above 6.1 mmol/L at fasting on visit 1, 2, 3 or 4)
- Women who are pregnant or breast feeding
- Any medical condition(s) or medication(s) known to significantly affect glucose metabolism. Significance to be assessed by the QI
- Use of medication, over-the-counter medication, natural health products or dietary supplements/probiotics that may affect glucose metabolism is prohibited during this study. Significance to be assessed by the QI. Participants who are taking allowed prescribed medications must agree to maintain their current method and dosing regimen during the course of the study unless other is recommended by their physician.
- Known Type I or Type II diabetes, including women who previously have had gestational diabetes.
- Use of antibiotics within 2 weeks of enrollment
- Metabolic diseases and/or chronic gastrointestinal diseases (IBS, Crohns etc.)
- Allergy to ingredients included in investigational product, reference, or standardized meal
- Participants restricted to a vegetarian or vegan diet
- Intolerance to gluten
- Individuals who are averse to venous catheterization or capillary blood sampling
- Currently active smokers (or using other tobacco products, and e-cigarettes)
- Unstable medical conditions as determined by QI
- Participation in other clinical research trials
- Individuals who are cognitively impaired and/or who are unable to give informed consent
- Acute infection
Any other condition which in the QI's opinion may adversely affect the individual's ability to complete the study or its measures or which may pose significant risk to the individual
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Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: Randomisert
- Intervensjonsmodell: Crossover-oppdrag
- Masking: Trippel
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Placebo komparator: Reference
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This intervention is based on white rice.
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Aktiv komparator: Whole cereal kernels Dose A
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This wholegrain intervention contains whole cereal kernels.
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Aktiv komparator: Whole cereal kernels Dose B
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This wholegrain intervention contains whole cereal kernels.
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Aktiv komparator: Cut cereal kernels Dose A
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This wholegrain intervention contains cut cereal kernels.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Postprandial capillary blood glucose iAUC (0-120 min)
Tidsramme: Outcome measures will be assessed just before and immediately after the standardized meal is consumed.
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The change in capillary blood glucose between wholegrain products and reference in the total incremental area under the curve iAUC(0-120 min) after the standardized breakfast meal.
|
Outcome measures will be assessed just before and immediately after the standardized meal is consumed.
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Postprandial capillary blood glucose Cmax
Tidsramme: Outcome measures will be assessed just before and immediately after the standardized meal is consumed.
|
The change in capillary blood glucose between wholegrain products and reference in 2-hour Cmax(0-120 min) (maximum concentration) after the breakfast meal.
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Outcome measures will be assessed just before and immediately after the standardized meal is consumed.
|
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Postprandial capillary blood glucose Tmax
Tidsramme: Outcome measures will be assessed just before and immediately after the standardized meal is consumed.
|
The change in capillary blood glucose between wholegrain products and reference in 2-hour Tmax(0-120 min) (the time to maximum concentration) after the breakfast meal.
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Outcome measures will be assessed just before and immediately after the standardized meal is consumed.
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Fasting capillary blood glucose
Tidsramme: Outcome measures will be assessed just before the standardized meal is consumed.
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The change in fasting capillary blood glucose the morning after consuming either wholegrain products or reference.
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Outcome measures will be assessed just before the standardized meal is consumed.
|
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Postprandial capillary blood glucose iAUC (0-60 min)
Tidsramme: Outcome measures will be assessed just before and immediately after the standardized meal is consumed.
|
The change in capillary blood glucose between wholegrain products and reference in the 1-hour incremental area under the curve iAUC(0-60 min) after the standardized breakfast meal.
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Outcome measures will be assessed just before and immediately after the standardized meal is consumed.
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Postprandial capillary blood glucose 2-hour iPeak(0-120 min) (incremental maximum value)
Tidsramme: Outcome measures will be assessed just before and immediately after the standardized meal is consumed.
|
The change in capillary blood glucose between wholegrain products and reference in the 2-hour iPeak(0-120 min) (incremental maximum value) after the breakfast meal.
|
Outcome measures will be assessed just before and immediately after the standardized meal is consumed.
|
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Postprandial Insulin iAUC(0-120 min)
Tidsramme: Outcome measures will be assessed just before and immediately after the standardized meal is consumed.
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The change in venous blood insulin between wholegrain products and reference in the total incremental area under the curve iAUC(0-120 min) after the standardized breakfast meal.
|
Outcome measures will be assessed just before and immediately after the standardized meal is consumed.
|
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Postprandial Insulin Cmax
Tidsramme: Outcome measures will be assessed just before and immediately after the standardized meal is consumed.
|
The change in venous blood insulin between wholegrain products and reference in Cmax after the standardized breakfast meal.
|
Outcome measures will be assessed just before and immediately after the standardized meal is consumed.
|
|
Postprandial Insulin Tmax
Tidsramme: Outcome measures will be assessed just before and immediately after the standardized meal is consumed.
|
The change in venous blood insulin between wholegrain products and reference in Tmax after the standardized breakfast meal.
|
Outcome measures will be assessed just before and immediately after the standardized meal is consumed.
|
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Fasting Insulin
Tidsramme: Outcome measures will be assessed just before and immediately after the standardized meal is consumed.
|
The change in fasting venous blood insulin the morning after consuming either wholegrain products or reference.
|
Outcome measures will be assessed just before and immediately after the standardized meal is consumed.
|
|
Postprandial insulin iAUC (0-60 min)
Tidsramme: Outcome measures will be assessed just before and immediately after the standardized meal is consumed.
|
The change in venous blood insulin between wholegrain products and reference in the 1-hour incremental area under the curve iAUC(0-60 min) after the standardized breakfast meal.
|
Outcome measures will be assessed just before and immediately after the standardized meal is consumed.
|
|
Postprandial venous blood insulin 2-hour iPeak(0-120 min) (incremental maximum value)
Tidsramme: Outcome measures will be assessed just before and immediately after the standardized meal is consumed.
|
The change in venous blood insulin between wholegrain products and reference in the 2-hour iPeak(0-120 min) (incremental maximum value) after the breakfast meal.
|
Outcome measures will be assessed just before and immediately after the standardized meal is consumed.
|
Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Fasting GLP-1
Tidsramme: Outcome measures will be assessed just before the standardized meal is consumed.
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The change in fasting GLP-1 the morning after consuming either wholegrain products or reference.
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Outcome measures will be assessed just before the standardized meal is consumed.
|
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GLP-1 iAUC(0-120 min)
Tidsramme: Outcome measures will be assessed just before and immediately after the standardized meal is consumed.
|
The change in GLP-1 between wholegrain products and reference in the total incremental area under the curve iAUC(0-120 min) after the standardized breakfast meal.
|
Outcome measures will be assessed just before and immediately after the standardized meal is consumed.
|
|
GLP-1 iAUC(0-60 min)
Tidsramme: Outcome measures will be assessed just before and immediately after the standardized meal is consumed.
|
The change in GLP-1 between wholegrain products and reference in the1-hour incremental area under the curve iAUC(0-60 min) after the standardized breakfast meal.
|
Outcome measures will be assessed just before and immediately after the standardized meal is consumed.
|
|
GLP-1 Cmax
Tidsramme: Outcome measures will be assessed just before and immediately after the standardized meal is consumed.
|
The changein GLP-1 between wholegrain products and reference in Cmax after the standardized breakfast meal.
|
Outcome measures will be assessed just before and immediately after the standardized meal is consumed.
|
|
GLP-1 Tmax
Tidsramme: Outcome measures will be assessed just before and immediately after the standardized meal is consumed.
|
The change in GLP-1 between wholegrain products and reference in Tmax after the standardized breakfast meal.
|
Outcome measures will be assessed just before and immediately after the standardized meal is consumed.
|
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Fasting PYY
Tidsramme: Outcome measures will be assessed just before the standardized meal is consumed.
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The change in fasting PYY the morning after consuming either wholegrain products or reference.
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Outcome measures will be assessed just before the standardized meal is consumed.
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PYY 2-hour mean concentration
Tidsramme: Outcome measures will be assessed just before and immediately after the standardized meal is consumed.
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The change in PYY between the wholegrain products and the reference in the 2-hour mean concentration after the breakfast meal.
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Outcome measures will be assessed just before and immediately after the standardized meal is consumed.
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PYY 1-hour mean concentration
Tidsramme: Outcome measures will be assessed just before and immediately after the standardized meal is consumed.
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The change in PYY between the wholegrain products and the reference in the 1-hour mean concentration after the breakfast meal.
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Outcome measures will be assessed just before and immediately after the standardized meal is consumed.
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Samarbeidspartnere og etterforskere
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Sponsor
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
17. mars 2022
Primær fullføring (Faktiske)
13. juni 2022
Studiet fullført (Faktiske)
13. juni 2022
Datoer for studieregistrering
Først innsendt
14. mars 2022
Først innsendt som oppfylte QC-kriteriene
14. mars 2022
Først lagt ut (Faktiske)
23. mars 2022
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
5. juli 2022
Siste oppdatering sendt inn som oppfylte QC-kriteriene
29. juni 2022
Sist bekreftet
1. mars 2022
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- TSP2201
Plan for individuelle deltakerdata (IPD)
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Nei
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